MAUDE Adverse Event Report: BD ALARIS¿ SMARTSITE¿ EXTENSION SET; INTRAVASCULAR ADMINISTRATION SET

Model Number 20028E

Device Problem Air/Gas in Device (4062)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/21/2021

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the bd alaris¿ smartsite¿ extension set filter did not filter out the air in the line while priming it.This complaint was created to capture the 2nd of 3 related incidents.The following information was provided by the initial reporter: "2- filter not filtering air when rn priming lines.".

Manufacturer Narrative

H6: investigation: no product or photo was returned by the customer.The customer complaint that the filter is not filtering air could not be verified due to the product not being returned for failure investigation.A device history record review for model 20028e lot number 21039640 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.A complaint history check was performed and this is the 1st related complaint reported with the defect/condition of air bubbles/air in line with lot #21039640 regarding item #20028e.

Event Description

It was reported that the bd alaris¿ smartsite¿ extension set filter did not filter out the air in the line while priming it.This complaint was created to capture the 2nd of 3 related incidents.The following information was provided by the initial reporter: "2- filter not filtering air when rn priming lines.".

• Brand Name: BD ALARIS¿ SMARTSITE¿ EXTENSION SET
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• MDR Report Key: 12485655
• MDR Text Key: 271914654
• Report Number: 9616066-2021-52071
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: K960280
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 09/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/04/2024
• Device Model Number: 20028E
• Device Catalogue Number: 20028E
• Device Lot Number: 21039640
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/20/2021
• Initial Date FDA Received: 09/16/2021
• Supplement Dates Manufacturer Received: 09/21/2021
• Supplement Dates FDA Received: 10/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1